0.2 mg and 0.4 mg film-coated tablets
Moxonidine
What Moxonidine Actavis is and what it is used for
Moxonidine Actavis is a medicine for high blood pressure. It works by affecting the central nervous system and has a blood pressure-lowering effect.
Moxonidine Actavis is used to treat mild to moderate blood pressure that is not organ-related ( essential hypertension ).
Moxonidine contained in Moxonidine Actavis may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Moxonidine Actavis
Do not use Moxonidine Actavis
- if you are allergic to the active substance moxonidine or any of the other ingredients of this medicine (listed in section 6).
- if you have a heart rhythm disorder (eg sick sinus syndrome, AV block II or III).
- if you have a low resting heart rate (less than 50 beats / minute at rest – bradycardia ).
- if you have heart failure (a condition in which the heart is unable to pump enough blood and which leads to shortness of breath and swelling in the legs).
Warnings and cautions
Talk to your doctor or pharmacist before taking Moxonidine Actavis
- if you have a heart problem called “AV block grade I”
- if you suffer from a severe blood supply disorder to the heart muscle (coronary heart disease) or symptoms such as chest pain at rest or with minimal exertion ( unstable angina pectoris).
- if you suffer from kidney disease. Your doctor will check your blood pressure regularly, especially at the beginning of treatment (if you are not sure, talk to your doctor).
- if you are using beta blockers at the same time . If this is the case, the beta-blocker must be discontinued first and then Moxonidine Actavis a few days later. This is to prevent a severe rise in blood pressure .
Older
The elderly may be more affected by the antihypertensive effect of Moxonidine Actavis. The doctor may therefore want to start with a lower dose and gradually increase the dose over time.
Children and young people
Moxonidine Actavis should not be given to children or adolescents under 16 years of age. (see section 3 “How to take Moxonidine Actavis”).
Treatment with Moxonidine Actavis must not be stopped abruptly, but discontinuation should be done gradually, following a doctor’s instruction, over two weeks.
Other medicines and Moxonidine Actavis
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The following effects of other drugs are possible and should therefore be carefully considered when combining:
- Concomitant treatment with other medicines given to lower blood pressure may increase the effect of Moxonidine Actavis.
- Moxonidine Actavis may increase the sedative effect of antidepressants, e.g. imipramine or amitriptyline ( tricyclic antidepressants ). At the same time, tricyclic antidepressants may reduce the effect of Moxonidine Actavis. Concomitant use is not recommended.
- Moxinidine Actavis may increase the effects of sedatives or hypnotics such as benzodiazepines ( diazepam , lorazepam).
- The active substance in Moxonidine Actavis is excreted by the kidneys (tubular secretion ). Other drugs that are also excreted via the same mechanism may affect the treatment effect of Moxonidine Actavis. Examples of such are:
- Sulfonureider tablets and insulin for the treatment of diabetes .
- Nitrates in the treatment of chest pain ( angina pectoris ).
- Digitalis glycosides (such as digoxin or digitoxin) in the treatment of heart failure .
- Medicines for rheumatism.
- Drugs that lower blood fats.
- Allopurinol, probenecid and colchicine in the treatment of gout .
- Cimetidine, among other things, in the treatment of heartburn and stomach ulcers .
- Thyroid extract in the treatment of insufficient thyroid function.
- Tolazoline (a medicine used to dilate blood vessels) may reduce the effect of Moxonidine Actavis.
Moxonidine Actavis with food, drink and alcohol
Moxonidine Actavis may increase the effect of alcohol.
Moxonidine Actavis can be taken before, during, or after a meal with enough water (a glass of water).
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Due to a lack of experience in the treatment of pregnant women, Moxonidine Actavis should not be used during pregnancy. If treatment is necessary, the treating physician assesses the benefits against the risks.
The active substance moxonidine passes into breast milk, therefore Moxonidine Actavis should not be used during breastfeeding. If treatment with Moxonidine Actavis is considered necessary, the mother should stop breastfeeding.
Driving and using machines
No studies on the effects of Moxonidine Actavis on the ability to drive and use machines have been performed. However, drowsiness and dizziness have been reported. You should be aware of this when driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Moxonidine Actavis contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Moxonidine Actavis
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Unless otherwise specified by your doctor, the following dosage is recommended:
Adults
At the beginning of the treatment:
- Treatment should start with 0.2 mg moxonidine per day.Moxonidine Actavis 0.2 mg film-coated tablets are available for this purpose.
Your doctor will adjust the dose if the desired effect is not achieved after three weeks:
- The dose can be increased to 0.4 mg moxonidine per day (equivalent to Moxonidine Actavis 0.4 mg film-coated tablet).
If the desired effect is still not achieved after another three weeks, your doctor will re-adjust the dose:
- 0.3 mg moxonidine twice daily.
Max doses:
The maximum single dose is 0.4 mg moxonidine at the same time.
The maximum total daily dose is 0.6 mg moxonidine.
Elderly patients
Provided that renal function is not impaired, it is the same recommended dose as for adults.
Use for children and adolescents
As there is the insufficient experience in the treatment of children and adolescents under 16 years of age, this age group should not be treated with Moxonidine Actavis.
Impaired renal function
If you have moderate renal impairment, your doctor will adjust the dose to suit you.
The starting dose is 0.2 mg daily which can be increased to a maximum of 0.4 mg daily if clinically justified and tolerated.
If you have severe renal impairment, your doctor will adjust the dose to suit you. Dose one should start at 0.2 mg and can be increased to a maximum of 0.3 mg per day if your doctor deems it appropriate for you.
Hepatic impairment
Patients with mild to moderate hepatic impairment:
The recommended dose is the same as for adults.
Please contact your doctor if you feel that the effect of Moxonidine Actavis is too strong or too weak.
If you use more Moxonidine Actavis than you should
When small children inadvertently take the medicine, the following signs may be seen:
drowsiness, small pupils, low blood pressure, difficulty breathing, coma.
The following are signs of overdose in adults:
Headache, drowsiness, drowsiness, low blood pressure at rest or when changing position which can cause dizziness and dizziness, weakness, low heart rate and dry mouth, vomiting, fatigue, stomach pain.
In case of severe overdose, the patient has difficulty breathing and has lost consciousness.
If you forget to use Moxonidine Actavis
Do not take a double dose to make up for a forgotten tablet. Instead, take the next dose when it is time for it.
If you stop using Moxonidine Actavis
Treatment with moxonidine must not be stopped abruptly.
Do not stop or stop taking Moxonidine Actavis without your doctor’s advice. Moxonidine Actavis should be discontinued gradually over two weeks.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Moxonidine Actavis and contact your doctor immediately if you get any of the following symptoms ( angioedema ):
- swelling of the face, tongue or throat
- difficulty swallowing
- hives and difficulty breathing.
Very common (more than 1 in 10 patients):
- Dry mouth
Common (more than 1 in 100 patients):
- Impact on thought processes (including inability to think clearly)
- Sleep disorders, drowsiness, listlessness, headache, dizziness, dizziness, insomnia
- Nausea, vomiting, diarrhea, constipation, upset stomach and other gastrointestinal symptoms
- Impotence
- Dilated blood vessels (may manifest as slight redness , slight skin swelling)
- Back pain
- Rash, itching
Uncommon (less than 1 in 100 and more than 1 in 1000 patients):
- Breast augmentation in men ( gynecomastia ), impotence , decreased sex drive
- Depression, anxiety, drowsiness, nervousness, fainting
- Dry, itchy, burning eyes
- Tinnitus
- Neck pain
- Problems with slow heart rhythm ( bradycardia )
- Allergic reactions, swelling under the skin ( angioedema )
- Inability to urinate ( urinary retention ) or inability to control bladder causing urinary leakage ( incontinence )
- Fluid retention ( edema ) in various places in the body
- Weakness in the legs
- Short-lived episodes of loss of consciousness
- Loss of appetite
- Pain in the parotid glands
- Low blood pressure , orthostatic hypotension (drop in blood pressure in connection with a change of position to a more upright position), paresthesias (tingling sensation in the arms and legs), painful whitening fingers and toes followed by a temporary redness and then redness (Raynauld’s syndrome), disorders in circulation in the arms and legs
You should contact your doctor immediately if you experience symptoms of angioneurotic edema ( angioedema ), an allergic reaction that causes swelling of the legs, arms, face, lips, tongue, oral mucosa, throat, or airways, resulting in shortness of breath and difficulty swallowing.
Rare (less than 1 in 10,000 patients, and isolated cases):
- Hepatic effects (hepatitis, cholestasis (blocked bile secretion) causing abdominal pain, jaundice (yellowing of the skin and whites of the eyes), itchy skin
How to store Moxonidine Actavis
Do not store above 30 ° C.
Store in the original package. Sensitive to light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the outer carton after EXP. or EXP. The expiration date is the last day of the specified month.
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is moxonidine. One film-coated tablet contains 0.2 mg and 0.4 mg moxonidine, respectively.
Other ingredients are:
Tablet core:
Lactose monohydrate, crospovidone, povidone K25, magnesium stearate.
Film coating:
hypromellose, titanium dioxide (E171), macrogol 400, red iron oxide (E172).
What the medicine looks like and contents of the pack
Moxonidine Actavis are round film-coated tablets. The 0.2 mg tablet is light pink and the 0.4 mg tablet is dark pink.
Moxonidine Actavis is available in the following packs: 10, 20, 28, 30, 50, 98, 100, 400 (20 x 20, 10 x 40 as hospital pack) film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Actavis Group PTC ehf.
Reykjavikurvegur 76-78
IS-220 Hafnarfjordur
Iceland
Manufacturer
Chanelle Medical
IDA Industrial Estate
Loughrea, Co. Galway
Ireland
Rottendorf Pharma GmbH
Ostenfelder Str. 51-61
59320 Ennigerloh
Germany
Actavis Group PTC ehf.
Reykjavikurvegur 76-78,
IS-220 Hafnarfjordur,
Iceland
Merckle GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany